A Healthy Volunteer Study to Evaluate Reversibility of Induced Impairment of Cognition

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Cognition

Treatments: Drug: donepezil; Drug: Placebo; Drug: AZD1446

Study type: Interventional

Funder types: Industry

Identifiers

NCT01044342

D2285M00021

Details and patient eligibility

About

The purpose of this study is to determine if cognitive impairment induced by scopolamine is reversed using donepezil and/or AZD1446 as compared to placebo, as assessed by electroencephalogram (EEG) measures.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 18-30
• Non-smoker for at least 4 weeks

Exclusion criteria

• Any clinically relevant acute or chronic disease
• Hypersensitivity to scopolamine
• History of substance abuse

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 4 patient groups, including a placebo group

A

Experimental group

Description:

Single dose of AZD1446 10 mg

Treatment:

Drug: AZD1446

Drug: AZD1446

B

Experimental group

Description:

Single dose of AZD1446 80 mg

Treatment:

Drug: AZD1446

Drug: AZD1446

C

Active Comparator group

Description:

Single Dose of Donepezil 5 mg

Treatment:

Drug: donepezil

D

Placebo Comparator group

Description:

Single dose of placebo to match AZD1446

Treatment:

Drug: Placebo